510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2239 of 3531

510(k) clearances, page 2239 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931715	Purecare at-903 t.e.n.s.	Fuching Enterprise Co., Ltd.	GZJ	Class II	1994-01-27
K931701	Immulite Pap	Siemens Healthcare Diagnostics Inc.	JFH	Class II	1994-01-27
K931540	Universal Bone Cement Kit	Biodynamic Technologies, Inc.	LZN	Class II	1994-01-27
K931329	Dental Instruments Curette Periodontal	Minnesota Prophy Power, Inc.	EMS	Class I	1994-01-27
K930844	Roche Abuscreen Ontrak Pos. Ref. Control-Methadone	Roche Diagnostic Systems, Inc.	LAS	Class I	1994-01-27
K925617	Mda Protein Assay	bioMerieux, Inc.	GGP	Class II	1994-01-27
K923499	Spectrolyse Heparin Kit	Biopool AB	KFF	Class II	1994-01-27
K923153	Hemocard, Hemoglobin C Assay	Isolab, Inc.	MLL	Class II	1994-01-27
K936076	Oral Ease Automatic Flosser/power Brush	Ohio Health Care Products, Inc.	JEQ	Class I	1994-01-26
K935972	Argeloy N.p. (V) (Non-Precious Dental Alloy for Procelain Application)	Argen Precious Metals, Inc.	EJH	Class II	1994-01-26
K935925	Vision Prophy Paste with Fluoride	Block Drug Company, Inc.	EJR	Class I	1994-01-26
K935829	Argeloy Partial (Non-Precious)	Argen Precious Metals, Inc.	EJH	Class II	1994-01-26
K935791	Phonak Piconet 232X-Az Bte Hearing Instrument	Phonak, Inc.	ESD	Class I	1994-01-26
K935736	Charisma Superlight	Kulzer GmbH	EBF	Class II	1994-01-26
K935718	Jedental Vlc Dental Curing Light	Jedental Co., Inc.	EAY	Class I	1994-01-26
K935592	Surgical Accessories Cocr Cable System	Surgical Accessories, Inc.	JDQ	Class II	1994-01-26
K935561	Interplak Home Plaque Removal Instrument	Bausch & Lomb Incorporated	JEQ	Class I	1994-01-26
K935522	Ranir Dental Tape Mint Waxed with Flouride	Ranir/Dcp Corp.	JES	Class I	1994-01-26
K935508	Argedent 78Pf	Argen Precious Metals, Inc.	EJT	Class II	1994-01-26
K935507	Argedent 77Pf	Argen Precious Metals, Inc.	EJT	Class II	1994-01-26
K935481	Sponger Cable System, Modification	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	1994-01-26
K935426	Preperitoneal Distention Balloon System	Origin Medsystems, Inc.	GCJ	Class II	1994-01-26
K935423	Cool Light 300	Endosurgical Development Corp.	GCT	Class II	1994-01-26
K935261	Kooliner II	GC America Inc.	EBI	Class II	1994-01-26
K935085	3M Dental Electrononic Anesthesia (Dea0 System 8670 Additional Applications	3M Company	LWM	Unclassified	1994-01-26
K935082	3M Dental Electronic Anesthesia (Dea) System 8670 Modification	3M Company	LWM	Unclassified	1994-01-26
K935041	3M Temporary Crown & Bridge Material	3M Company	EBG	Class II	1994-01-26
K934947	Bii-Plast	Bio-Interfaces, Inc.	LYC	Class II	1994-01-26
K934920	Vb-1830/Vb-1530, Video Bronchoscope	Pentax Precision Instrument Corp.	EOQ	Class II	1994-01-26
K934703	Medicool Protectall	Avc Regulatory Compliance/Technical Services	LDQ		1994-01-26
K934667	Methadone Enzyme Immunoassay	Diagnostic Reagents, Inc.	DJR	Class II	1994-01-26
K934596	Bisco Duo Link D/c Luting Composite	Bisco, Inc.	KLE	Class II	1994-01-26
K934583	Burrs	American Medical Specialties, Inc.	GFF	Class I	1994-01-26
K934390	Oscillating Bone Saw Blade, 6200 Series	Boehringer Laboratories, LLC	GFA	Class I	1994-01-26
K934298	King Krib	Noritage, Inc.	FNJ	Class I	1994-01-26
K934260	Barrier Bone Wax Applicator	Phillips Pharmaceuticals, Inc.	LXH	Class I	1994-01-26
K934158	5Mm Calibrated Suction Cannula	Phx Technologies Corp.	GCJ	Class II	1994-01-26
K934157	Hydro-Probe	Phx Technologies Corp.	GCJ	Class II	1994-01-26
K934073	Jedental Glass Ionomer Cement and Liner	Jedental Co., Inc.	EMA	Class II	1994-01-26
K934030	Sterile Tracheostomy Tray	Surgipro, Inc.	LRO	Class II	1994-01-26
K933921	Acuflex Disposable Knives	Acufex Microsurgical, Inc.	HTS	Class I	1994-01-26
K933766	High-Q-Bond	Silmet U.S.A. Corp.	EBF	Class II	1994-01-26
K933745	Permagen Universal Bonding Resin	Bio-Systems Research	EBH	Class I	1994-01-26
K933636	Dispose-a-Sheet	Belmac Healthcare Corp.	KME	Class I	1994-01-26
K933590	Baxter Reinforced Expanded PTFE Vascular Graft	Baxter Healthcare Corporation	DSY	Class II	1994-01-26
K933334	Magic Torque Guidewire	Boston Scientific Corporation	DQX	Class II	1994-01-26
K933311	Motorized Electric Parallel Bars	Midland Mfg. Co.	BXB	Class I	1994-01-26
K933071	Sts 701 Transport Stretcher	Wy'east Medical Corp.	FPO	Class II	1994-01-26
K932881	Olympic Warm-Lamp	Olympic Medical Corp.	ILY	Class II	1994-01-26
K932856	Irrigation Access Cap	Mcgaw, Inc.	FPA	Class II	1994-01-26